PAciFY Study: A clinical trial investigating the effects of morphine on IPF cough

Upcoming study
Expected to open
This study is currently recruiting
Expected to close August 2022
This study is closed
This study closed in August 2022
We will update this page with study results when available.
Information on study results are included below
This study closed in August 2022

What next?

The PAciFY Study was a Phase 3 clinical trial. The study looked at what the effect of a low dose of morphine may have on cough count and the quality of life of patients with idiopathic pulmonary fibrosis (IPF). People who took part were given morphine and a placebo (a tablet that looks just like the morphine but contains no active ingredients) at different times during the study. Forty-three people took part in the 7 week study. This was a relatively short study, so the long term use cannot be spoken for.

Dr Zhe Wu, Clinical Fellow in Interstitial Lung Disease, provided us with an update of the results:

Cough affects approximately 85% of patients with idiopathic pulmonary fibrosis and for some it can be particularly troublesome. The PAciFy Cough trial represents an important breakthrough and is one of the first treatments proven to be effective.
The results showed that treatment with low-dose slow-release morphine sulfate for two weeks led to a 39% reduction in the frequency of cough and improved patients’ quality of life when compared with placebo.
In addition, patients tolerated the treatment extremely well and only one-fifth of subjects developed mild constipation. The good news is that this treatment is already available to patients and is already widely used for other conditions. However, further studies are still needed to assess whether its use remains effective in the long term.

Moving forwards, low dose controlled release morphine could be an effective treatment option for cough in patients with IPF. The next steps for research towards this happening are studies that look at what happens over a longer period of time, to ensure that its long term use is safe and effective.

If you experience challenges associated with cough, please speak to your healthcare team to see if there are management strategies or treatments available to you. There are also ongoing cough research studies that are currently recruiting for participants, please speak to your healthcare team to express your interest or find out more using our online Study Finder.

If you would like to read more about the study results, please take a look at the Lancet journal article.

Original listing:

What next?

The PAciFY Study was a Phase 3 clinical trial. The study looked at what the effect of a low dose of morphine may have on cough count and the quality of life of patients with idiopathic pulmonary fibrosis (IPF). People who took part were given morphine and a placebo (a tablet that looks just like the morphine but contains no active ingredients) at different times during the study. Forty-three people took part in the 7 week study. This was a relatively short study, so the long term use cannot be spoken for.

Dr Zhe Wu, Clinical Fellow in Interstitial Lung Disease, provided us with an update of the results:

Cough affects approximately 85% of patients with idiopathic pulmonary fibrosis and for some it can be particularly troublesome. The PAciFy Cough trial represents an important breakthrough and is one of the first treatments proven to be effective.
The results showed that treatment with low-dose slow-release morphine sulfate for two weeks led to a 39% reduction in the frequency of cough and improved patients’ quality of life when compared with placebo.
In addition, patients tolerated the treatment extremely well and only one-fifth of subjects developed mild constipation. The good news is that this treatment is already available to patients and is already widely used for other conditions. However, further studies are still needed to assess whether its use remains effective in the long term.

Moving forwards, low dose controlled release morphine could be an effective treatment option for cough in patients with IPF. The next steps for research towards this happening are studies that look at what happens over a longer period of time, to ensure that its long term use is safe and effective.

If you experience challenges associated with cough, please speak to your healthcare team to see if there are management strategies or treatments available to you. There are also ongoing cough research studies that are currently recruiting for participants, please speak to your healthcare team to express your interest or find out more using our online Study Finder.

If you would like to read more about the study results, please take a look at the Lancet journal article.

Original listing:

About this study

The cause of cough in pulmonary fibrosis is not fully understood, but researchers around the world are trying to better understand and treat this distressing symptom. The PAciFY Study is investigating whether morphine (a widely used strong painkiller) can reduce the amount IPF patients’ cough and improve their quality of life.

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What is involved?

This study involves taking morphine and a placebo at different times during the trial. You would need to visit the hospital 3 times, and also be contacted via telephone or video communication twice over the course of 7 weeks.

You would have medical assessments, including blood tests, and be asked to wear a cough monitor and Fitbit device 4 times during the study, each for a period of 24 hours. There are surveys to complete, which will be sent to you via email.

Summary of involvement

7 weeks participation

Taking a drug

Medical assessments

Wearing a cough monitor

Completing surveys

Can I take part?

You may be able to take part if you have received a diagnosis of IPF in the last 5 years and have had a cough for more than 8 weeks.

Unfortunately, you will not be able to take part in this study if you do not have a diagnosis of IPF, or if a measurement of your lung function (known as Forced Vital Capacity, FVC) is less than 45%.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the clinical trial team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.

To find our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

Diagnosis of IPF within last 5 years

A cough for more than 8 weeks

Aged between 40 and 90

You will not be able to join the study of any of the following applies:

You do not have a diagnosis of IPF

A measurement of your lung function (known as Forced Vital Capacity, FVC) is less than 45%

What difference could taking part make?

Taking part in this clinical trial will help researchers to identify the potential effects of morphine on IPF cough. The study will help to gain greater understanding of the medication and if it has the potential to help people affected by IPF.

Taking part in research has the potential to make a difference for people who have IPF now and for future generations.

Where does the study take place?

Study locations

Royal Brompton Hospital, London

Aintree University Hospital, Liverpool

Patients who are willing to travel to take part in the study may also be eligible to participate. Speak to your clinical team or email pacify@rbht.nhs.uk to find out more.

How to take part

Further information

The summary on this page provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.

If you have any questions about this research study, please speak to your medical team and contact the researchers directly via:

pacify@rbht.nhs.uk

This study is supported by

Royal Brompton and Harefield NHS Foundation Trust
Newcastle Fibrosis Research Group, Newcastle University
Study ID number:
NCT04429516

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.

Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email research@actionpf.org